Study to Evaluate the Clinical Performance of Deseyne (Vifilcon C) Daily Disposable Soft Contact Lens

Completed · Not applicable

Conditions studied: Refractive Error - Myopia Bilateral

In brief

This clinical study is to provide clinical performance data comparing the test lens (Deseyne \[vifilcon C\] daily disposable soft contact lens) to a control lens (1-Day Acuvue Moist \[etafilcon A\] daily disposable soft contact lens) in the same indication for use (single use prior to removal followed by a fresh lens upon the next lens wear exposure). The study is designed to test the hypothesis that the test lens is substantially equivalent to the control lens in like indications for use.

Key facts

Study ID

NCT05927753

Run by

Bruno Vision Care

People needed

81

Starts

2023-06-08

Expected to finish

2024-01-08

Last updated by the study team

2025-10-02

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18 to 40 years of age on the date the informed consent form (ICF) is signed
• Presence of clear central corneas and absence of any anterior segment disorders in each eye
• Presence of myopia and requirement for lens correction from -1.00 D to -6.00 D in each eye
• Best-corrected distance visual acuity (BCDVA) of 50 ETDRS letters (0.1 logMAR) or better in each eye
• Be an adapted soft contact lens wearer in each eye and agree to wear study lenses in each eye on a daily wear basis and not wear a non-study lens for approximately 3 months
• Able and willing to comply with all treatment and follow-up/study procedures
• Able to read, understand, and provide written informed consent on the IRB-approved ICF and provide authorization as appropriate for local privacy regulations

You may not qualify if…

• Participation in any drug or device clinical investigation within 2 weeks prior to Screening and/or during the period of study participation
• Women of childbearing potential (those who are not surgically sterilized or postmenopausal) who meet any of the following conditions:
• Currently pregnant
• Plans to become pregnant during the study
• Currently breastfeeding
• History of gas permeable lens wear in either eye within 30 days prior to Screening or history of polymethylmethacrylate lens wear in either eye within 3 months prior to Screening
• Current monovision, multifocal, or toric contact lens wear in either eye
• In either eye, current nonabsorbable punctal plug or implantation of absorbable punctal plug within 2 to 6 months (depending on type of absorbable plug) prior to Screening, or punctal plug removal within 2 months prior to Screening. Permanent punctal occlusion in 1 or more puncta or nasolacrimal duct obstruction in either eye is excluded
• Use of any prescription ocular medication throughout the duration of the study. Prescription eyedrops for dry eye disease (eg, Restasis, Xiidra, Cequa, Eysuvis), as well as nasally administered Tyrvaya, must be discontinued 2 weeks prior to Screening and are prohibited throughout the duration of the study Clinical Study Protocol Version 3.0, 26 April 2023 Page 17 of 66 Bruno Vision Care Protocol 22001
• Use of over-the-counter eyedrops (eg, oxymetazoline, naphazoline, ketotifen, etc.), except for unpreserved lubricant eyedrops or artificial tears (eg, Systane, Refresh), within 1 week prior to Screening and throughout the duration of the study
• Use of any systemic or topical medications that may, in the Investigator's opinion, affect ocular physiology or lens performance
• Anisometropia (spherical equivalent) >2.00 D
• Ocular astigmatism >1.00 D in either eye
• Amblyopia in either eye
• Aphakia in either eye
• Active ocular disease (eg, dry eye disease, blepharitis, conjunctivitis, keratitis, etc.) in either eye. Subjects must be symptom free for at least 7 days
• History or evidence of ocular infection within 30 days prior to Screening
• History or evidence of ocular herpes simplex or ocular herpes zoster
• Any grade corneal infiltrates in either eye
• Grade ≥2 finding in either eye during slit lamp examination
• Any "Present" finding in either eye during slit lamp examination that, in the Investigator's opinion, may interfere with contact lens wear
• Any scar or neovascularization within the central 4 mm of the cornea in either eye. Subjects with minor peripheral corneal scarring (not extending into the central area) that, in the Investigator's opinion, does not interfere with contact lens wear are eligible to participate in this study
• History of any corneal surgery (eg, refractive surgery or therapeutic) in either eye
• Any systemic disease currently affecting ocular health or which, in the Investigator's opinion, may have an effect on ocular health in either eye during the course of the study
• Allergy to any component in the study care products

Where it is running

• Omega Vision Center PA — Longwood, Florida, United States
• Kennaar Eye Care — Pittsburg, Kansas, United States
• West Bay Eye Associates — Warwick, Rhode Island, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.